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PROZAC 20MG/5ML LIQUID

Active substance(s): FLUOXETINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Prozac 20mg/5ml Liquid / Fluoxetine Liquid 20mg/5ml
(fluoxetine hydrochloride)
This product is available using any of the above names but will be referred to as Prozac
throughout the following leaflet.
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT PROZAC
Prozac treats depression and anxiety disorders.
Like all medicines it can have unwanted effects. It is therefore important that you and your
doctor weigh up the benefits of treatment against the possible unwanted effects, before
starting treatment.
Prozac is not for use in children and adolescents under 18. See section 2, Children
and adolescents aged 8 to 18 years.
Prozac won’t work straight away. Some people taking antidepressants feel worse before
feeling better. Your doctor should ask to see you again a couple of weeks after you first
start treatment. Tell your doctor if you haven’t started feeling better. See section 3, How to
take Prozac.
Some people who are depressed or anxious think of harming or killing themselves. If
you start to feel worse, or think of harming or killing yourself, see your doctor or go to a
hospital straight away. See section 2.
Don’t stop taking Prozac without talking to your doctor. If you stop taking Prozac
suddenly or miss a dose, you may get withdrawal effects. See section 3 for further
information.
If you feel restless and feel like you can’t sit or stand still, tell your doctor. Increasing
the dose of Prozac may make these feelings worse. See section 4, Possible side-effects.
Taking some other medicines with Prozac can cause problems. You may need to talk
to your doctor. See section 2, Taking other medicines.
If you are pregnant or planning to get pregnant, talk to your doctor. See section 2,
Pregnancy, breast-feeding and fertility.
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Prozac is and what it is used for
2. What you need to know before you take Prozac
3. How to take Prozac
4. Possible side effects
5. How to store Prozac
6. Content of the pack and other information
1. What is Prozac and what it is used for
Prozac 20mg/5ml Liquid contains the active substance fluoxetine which is one of a group of
medicines called selective serotonin re-uptake inhibitors (SSRI) antidepressants.
This medicine is used to treat the following conditions:
Adults:
 Major depressive episodes
 Obsessive-compulsive disorder
 Bulimia nervosa: Prozac is used alongside psychotherapy for the reduction of bingeeating and purging.
Children and adolescents aged 8 years and above:
 Moderate to severe major depressive disorder, if the depression does not respond to
psychological therapy after 4-6 sessions. Prozac should be offered to a child or young
person with moderate to severe major depressive disorder only in combination with
psychological therapy.
How Prozac works
Everyone has a substance called serotonin in their brain. People who are depressed or
have obsessive-compulsive disorder or bulimia nervosa have lower levels of serotonin than
others. It is not fully understood how Prozac and other SSRIs work but they may help by
increasing the level of serotonin in the brain. Treating these conditions is important to help
you get better. If it’s not treated, your condition may not go away and may become more
serious and more difficult to treat.
You may need to be treated for a few weeks or months to ensure that you are free from
symptoms.
2. What you need to know before you take Prozac
Do not take Prozac if you are:
 allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6).
If you develop a rash or other allergic reactions (like itching, swollen lips or face
or shortness of breath), stop taking the oral liquid straight away and contact your
doctor immediately.
 taking other medicines known as irreversible, non-selective monoamine oxidase
inhibitors (MAOIs), since serious or even fatal reactions can occur (e.g. iproniazid used
to treat depression).
Treatment with Prozac should only be started at least 2 weeks after discontinuation of an
irreversible, non-selective MAOI.
Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking
Prozac. If Prozac has been prescribed for a long period and/ or at a high dose, a longer
interval needs to be considered by your doctor.
 taking metoprolol (to treat heart failure) because there is an increased risk of your heart
beat becoming too slow.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prozac if any of the following applies to you:
 heart problems;
 appearance of fever, muscle stiffness or tremor, changes in your mental state like
confusion, irritability and extreme agitation; you may suffer from the so-called “serotonin
syndrome” or “neuroleptic malignant syndrome”. Although this syndrome occurs rarely it
may result in potentially life threatening conditions; contact your doctor immediately,
since Prozac might need to be discontinued.
 mania now or in the past; if you have a manic episode, contact your doctor immediately
because Prozac might need to be discontinued;
 history of bleeding disorders or appearance of bruises or unusual bleeding;
 ongoing treatment with medicines that thin the blood (see ‘Other medicines and
Prozac’);
 epilepsy or fits. If you have a fit (seizures) or experience an increase in seizure
frequency, contact your doctor immediately; Prozac might need to be discontinued;
 ongoing ECT (electro-convulsive therapy);
 ongoing treatment with tamoxifen (used to treat breast cancer) (see ‘Other medicines
and Prozac’);
 starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of
Prozac may make this worse;
 diabetes (your doctor may need to adjust your dose of insulin or other antidiabetic
treatment);
 liver problems (your doctor may need to adjust your dosage);

 low resting heart-rate and/or if you know that you may have salt depletion as a result of
prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water
tablets);
 ongoing treatment with diuretics (water tablets), especially if you are elderly;
 glaucoma (increased pressure in the eye).
Thoughts of suicide and worsening of your depression or anxiety disorder.
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of
harming or killing yourself. These may be increased when first starting antidepressants,
since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
 If you have previously had thoughts about killing or harming yourself.
 If you are a young adult. Information from clinical trials has shown an increased risk of
suicidal behaviour in adults aged less than 25 years with psychiatric conditions who
were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go
to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have
an anxiety disorder, and ask them to read this leaflet.
You might ask them to tell you if they think your depression or anxiety is getting worse, or if
they are worried about changes in your behaviour.
Children and adolescents aged 8 to 18 years:
Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when
they take this class of medicines. Prozac should only be used in children and adolescents
aged 8 to 18 years for the treatment of moderate to severe major depressive episodes (in
combination with psychological therapy) and it should not be used to treat other conditions.
Additionally, only limited information concerning the long-term safety of Prozac on growth,
puberty, mental, emotional and behavioural development in this age group is available.
Despite this, and if you are a patient under 18, your doctor may prescribe Prozac for
moderate to severe major depressive episodes, in combination with psychological therapy,
because he/she decides that this is in your best interests. If your doctor has prescribed
Prozac for a patient under 18 and you want to discuss this, please go back to your doctor.
You should inform your doctor if any of the symptoms listed above develop or worsen when
patients under 18 are taking Prozac.
Prozac should not be used in the treatment of children under the age of 8 years.
Other medicines and Prozac
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take Prozac with:
 Certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs), some
used to treat depression. Irreversible, non-selective MAOIs must not be used with
Prozac as serious or even fatal reactions (serotonin syndrome) can occur (see section
“Do not take Prozac”). Treatment with Prozac should only be started at least 2 weeks
after discontinuation of an irreversible, non-selective MAOI (for instance
tranylcypromine). Do not take any irreversible, non-selective MAOIs for at least 5
weeks after you stop taking Prozac. If Prozac has been prescribed for a long period
and/or at a high dose, a longer interval than 5 weeks may need to be considered by
your doctor.
 metoprolol when used for heart failure; there is an increased risk of your heart beat
becoming too slow.
Prozac may affect the way the following medicines work (interaction):
 tamoxifen (used to treat breast cancer); because Prozac may change the blood levels
of this drug, resulting in the possibility of a reduction in the effect of tamoxifen, your
doctor may need to consider prescribing a different antidepressant treatment.
 monoamine oxidase inhibitors A (MAOI-A) including moclobemide, linezolid (an
antibiotic) and methylthioninium chloride (also called methylene blue, used for the
treatment of medicinal or chemical product induced methemoglobinemia): due to the
risk of serious or even fatal reactions (called serotonin syndrome). Treatment with
fluoxetine can be started the day after stopping treatment with reversible MAOIs but the
doctor may wish to monitor you carefully and use a lower dose of the MAOI-A drug.
 mequitazine (for allergies); because taking this drug with Prozac may increase the risk
of changes in the electrical activity of the heart.
 phenytoin (for epilepsy); because Prozac may influence the blood levels of this drug,
your doctor may need to introduce phenytoin more carefully and carry out check-ups
when given with Prozac.
 lithium, selegiline, St. John’s Wort, tramadol (a painkiller), triptans (for migraine)
and tryptophan; there is an increased risk of mild serotonin syndrome when these
drugs are taken with Prozac. Your doctor will carry out more frequent check-ups.
 medicines that may affect the heart’s rhythm, e.g. Class IA and III antiarrhythmics,
antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic
antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin,
erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine or
certain antihistamines (astemizole, mizolastine), because taking one or more of these
drugs with Prozac may increase the risk of changes in the electrical activity of the heart.
 Anti-coagulants (such as warfarin), NSAID (such as ibuprofen, diclofenac), aspirin
and other medicines which can thin the blood (including clozapine, used to treat
certain mental disorders). Prozac may alter the effect of these medicines on the blood.
If Prozac treatment is started or stopped when you are taking warfarin, your doctor will
need to perform certain tests, adjust your dose and check on you more frequently.
 cyproheptadine (for allergies); because it may reduce the effect of Prozac.
 drugs that lower sodium levels in the blood (including, drug that causes increase in
urination, desmopressin, carbamazepine and oxcarbazepine); because these drugs
may increase the risk of sodium levels in the blood becoming too low when taken with
Prozac.
 anti-depressants such as tricyclic anti-depressants, other selective serotonin reuptake
inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria),
tramadol (used to treat severe pain) or anti-psychotics such as phenothiazines or
butyrophenones; because Prozac may increase the risk of seizures when taken with
these medicines.
 flecainide, propafenone, nebivolol or encainide (for heart problems),
carbamazepine (for epilepsy), atomoxetine or tricyclic antidepressants (for example
imipramine, desipramine and amitriptyline) or risperidone (for schizophrenia);
because Prozac may possibly change the blood levels of these medicines, your doctor
may need to lower their dose when administered with Prozac.
Prozac with food, drink and alcohol
 You can take Prozac with or without food, whatever you prefer.
 You should avoid alcohol while you are taking this medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Talk to your doctor as soon as possible if you’re pregnant, if you might be pregnant, or if
you’re planning to become pregnant.
In babies whose mothers took fluoxetine during the first few months of pregnancy, there
have been some studies describing an increased risk of birth defects affecting the heart. In
the general population, about 1 in 100 babies are born with a heart defect. This increased
to about 2 in 100 babies in mothers who took fluoxetine.
When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like
fluoxetine may increase the risk of a serious condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish.
These symptoms usually begin during the first 24 hours after the baby is born. If this
happens to your baby you should contact your midwife and/or doctor immediately.

It is preferable not to use this treatment during pregnancy unless the potential benefit
outweighs the potential risk. Thus, you and your doctor may decide to gradually stop taking
Prozac while you are pregnant or before being pregnant. However, depending on your
circumstances, your doctor may suggest that it is better for you to keep taking Prozac.
Caution should be exercised when used during pregnancy, especially during late
pregnancy or just before giving birth since the following effects have been reported in new
born children: irritability, tremor, muscle weakness, persistent crying, and difficulty in
sucking or in sleeping.
Breast-feeding
Fluoxetine is excreted in breast milk and can cause side effects in babies. You should only
breast-feed if it is clearly necessary. If breast-feeding is continued, your doctor may
prescribe a lower dose of fluoxetine.
Fertility
Fluoxetine has been shown to reduce the quality of sperm in animal studies. Theoretically,
this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Psychotropic drugs such as Prozac may affect your judgment or co-ordination. Do not drive
or use machinery until you know how Prozac affects you.
Prozac contains sucrose and ethanol
Prozac contains sucrose. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal product.
The flavouring for this medicinal product contains small amounts of ethanol (alcohol), less
than 100 mg per dose (see Section 6).
3. How to take Prozac
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure. Do not take more medicine than your doctor
tells you.
Measure the right amount of medicine using the measuring cup, syringe or a measuring
spoon, then drink it.
Adults:
The recommended dose is:
 Depression: The recommended dose is 5 ml oral liquid (20 mg) daily. Your doctor will
review and adjust your dosage if necessary within 3 to 4 weeks of the start of treatment.
If required, the dosage can be gradually increased up to a maximum of 15ml oral liquid
(60 mg) daily. The dose should be increased carefully to ensure that you receive the
lowest effective dose. You may not feel better immediately when you first start taking
your medicine for depression. This is usual because an improvement in depressive
symptoms may not occur until after the first few weeks. Patients with depression should
be treated for at least 6 months.
 Bulimia nervosa: The recommended dose is 15 ml oral liquid (60 mg) daily.
 Obsessive-compulsive disorder: The recommended dose is 5 ml oral liquid (20 mg)
daily. Your doctor will review and adjust your dosage if necessary after 2 weeks of
treatment. If required, the dosage can be gradually increased up to a maximum of 15 ml
oral liquid (60 mg) daily. If no improvement is noted within 10 weeks, your doctor will
reconsider your treatment.
Use in children and adolescents aged 8 to 18 years with depression:
Treatment should be started and be supervised by a specialist. The starting dose is 10
mg/day (given as 2.5 ml of Prozac). After 1 to 2 weeks, your doctor may increase the dose
to 20 mg/day. The dose should be increased carefully to ensure that you receive the lowest
effective dose. Lower weight children may need lower doses. If there is a satisfactory
response to treatment, your doctor will review the need for continuing treatment beyond 6
months. If you have not improved within 9 weeks, your doctor will reassess your treatment.
Elderly:
Your doctor will increase the dose with more caution and the daily dose should generally
not exceed 10 ml oral liquid (40 mg). The maximum dose is 15 ml oral liquid (60 mg) daily.
Liver impairment:
If you have a liver problem or are using other medication that might affect Prozac, your
doctor may decide to prescribe a lower dose or tell you to use Prozac every other day.
If you take more Prozac than you should
 If you take too much, go to your nearest hospital emergency department (or casualty) or
tell your doctor straight away.
 Take the bottle of Prozac with you if you can.
Symptoms of overdose include: nausea, vomiting, seizures, heart problems (like irregular
heart beat and cardiac arrest), lung problems and change in mental condition ranging from
agitation to coma.
If you forget to take Prozac
 If you miss a dose, do not worry. Take your next dose the next day at the usual time.
Do not take a double dose to make up for a forgotten dose.
 Taking your medicine at the same time each day may help you to remember to take it
regularly.
If you stop taking Prozac
 Do not stop taking Prozac without asking your doctor first, even when you start to feel
better. It is important that you keep taking your medicine.
 Make sure you do not run out of medicine.
You may notice the following effects (withdrawal effects) when you stop taking Prozac:
dizziness; tingling feelings like pins and needles; sleep disturbances (vivid dreams,
nightmares, inability to sleep); feeling restless or agitated; unusual tiredness or weakness;
feeling anxious; nausea/ vomiting (feeling sick or being sick); tremor (shakiness);
headaches.
Most people find that any symptoms on stopping Prozac are mild and disappear within a
few weeks. If you experience symptoms when you stop treatment, contact your doctor.
When stopping Prozac, your doctor will help you to reduce your dose slowly over one or
two weeks – this should help reduce the chance of withdrawal effects.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
 If you have thoughts of harming or killing yourself at any time, contact your doctor or
go to a hospital straight away (see Section 2).
 If you get a rash or allergic reaction such as itching, swollen lips/tongue or wheezing/
shortness of breath, stop taking the medicine straight away and tell your doctor
immediately.
 If you feel restless and cannot sit or stand still, you may have akathisia; increasing your
dose of Prozac may make you feel worse. If you feel like this, contact your doctor.
 Tell your doctor immediately if your skin starts to turn red or you develop a varied
skin reaction or your skin starts to blister or peel. This is very rare.
The most frequent sides effects (very common side effects that may affect more than 1
user in 10) are insomnia, headache, diarrhoea, feeling sick (nausea) and fatigue.
Some patients have had:
 a combination of symptoms (known as “serotonin syndrome”) including unexplained
fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion,
extreme agitation or sleepiness (only rarely);
 feelings of weakness, drowsiness or confusion mostly in elderly people and in (elderly)
people taking diuretics (water tablets);
 prolonged and painful erection;
 irritability and extreme agitation;

 heart problems, such as fast or irregular heart rate, fainting, collapsing or dizziness
upon standing which may indicate abnormal functioning of the heart rate.
If you have any of the above side effects, you should tell your doctor immediately.
The following side effects have also been reported in patients taking Prozac:
Common (may affect up to 1 in 10 people)
 not feeling hungry, weight loss
 nervousness, anxiety
 restlessness, poor concentration
 feeling tense
 decreased sex drive or sexual problems (including difficulty maintaining an erection for
sexual activity)
 sleep problems, unusual dreams, tiredness or sleepiness
 dizziness
 change in taste
 uncontrollable shaking movements
 blurred vision
 rapid and irregular heartbeat sensations
 flushing
 yawning
 indigestion, vomiting
 dry mouth
 rash, urticaria, itching
 excessive sweating
 joint pain
 passing urine more frequently
 unexplained vaginal bleeding
 feeling shaky or chills
Uncommon (may affect up to 1 in 100 people)
 feeling detached from yourself
 strange thinking
 abnormally high mood
 orgasm problems
 thoughts of suicide or harming yourself
 teeth grinding
 muscle twitching, involuntary movements or problems with balance or co-ordination
 memory impairment
 enlarged (dilated) pupils
 ringing in the ears
 low blood pressure
 shortness of breath
 nose bleeds
 difficulty swallowing
 hair loss
 increased tendency to bruising
 unexplained bruising or bleeding
 cold sweat
 difficulty passing urine
 feeling hot or cold
 abnormal liver test results
Rare (may affect up to 1 in 1,000 people)
 low levels of salt in the blood
 reduction in blood platelets, which increases risk of bleeding or bruising
 reduction in white blood cell count
 untypical wild behaviour
 hallucinations
 agitation
 panic attacks
 confusion
 stuttering
 aggression
 fits
 vasculitis (inflammation of a blood vessel)
 rapid swelling of the tissues around the neck, face, mouth and/or throat
 pain in the tube that takes food or water to your stomach
 hepatitis
 lung problems
 sensitivity to sunlight
 muscle pain
 problems urinating
 producing breast milk
Bone fractures – an increased risk of bone fractures has been observed in patients taking
this type of medicines.
Most of these side effects are likely to disappear with continued treatment.
In children and adolescents (8-18 years) – In addition to the possible side effects listed
above, Prozac may slow growth or possibly delay sexual maturity. Suicide-related
behaviours (suicide attempt and suicidal thoughts), hostility, mania and nose bleeds were
also commonly reported in children.
Prozac contains sugar which may be harmful to the teeth.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store Prozac
 Do not store above 30°C. Store in the original container to protect from light.
 Keep out of the sight and reach of children.
 Do not take Prozac after the expiry date which is printed on the carton label or bottle
label. The expiry date refers to the last day of that month.
 If the liquid becomes discoloured or shows any other signs of deterioration, you should
consult your pharmacist who will tell you what to do.
 Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
to protect the environment.
6. Content of the pack and other information
What Prozac contains
Your medicine is called Prozac 20mg/5ml liquid. Each 5ml contains 20mg of the active
ingredient Fluoxetine, as the hydrochloride, in a clear, colourless liquid, smelling of mint.
Prozac also contains the following inactive ingredients:
Benzoic acid, Sucrose, Glycerol, Mint flavouring and Purified Water.
What Prozac looks like and contents of the pack
Prozac is available in a 70ml brown glass bottle supplied with a syringe.
Manufacturer
Manufactured by Patheon France, 40, boulevard de Champaret, 38300, Bourgoin-Jallieu,
France and procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
POM
PL No: 15814/0148
Leaflet revision and issue date (Ref.) 29.04.2016.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
Prozac is a registered trade mark of Eli Lily and Company, U.S.A.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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